Recall Z-2746-2016 ยท FQO Table, Operating-Room, Ac-Powered
Maquet Cardiovascular Us Sales, Llc
The Connecting Bracket (Fixture) Device (1002.65A0) is designed as a connecting element to support ancillary head rests on a Maquet operating room table immediately before, during and after surgical interventions as well as for examination and treatment. The fixture is used to adapt a range of different head and horseshoe head rests with a central square mount
| Date | Aug 12, 2016 |
| Status | Terminated |
| Reason | Post Market Surveillance cases reported to Maquet showing instances in which the welded joint between the square mount and the first fixable swivel joint of Maquet's Connecting Bracket (Fixture) Device is broken. |
| Root cause | Use error |
| Action | Maquet sent an "Urgent Product Recall Medical Device Correction Letter and Medical Device Correction Response Form" dated August 12, 2016 via UPS to their affected customers. Customers were advised to inspect all devices that include the fixture for damage before every use. Customers were asked to fill out and sign the enclosed Medical Device Correction Response Form and return it via email to FieldAction@maquet.com or fax to 1-973-909-9927. Customers with questions were advised to contact their MAQUET Representative or call MAQUET Customer Service at 1-888-627-8383. For questions regardin |
| Quantity | 19 units (US) and 1975 units (OUS) |
| Distribution | Nationwide Distribution to CA, FL, IA, IN, MO, UT and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.